BIOINDUSTRIAL ONLINE ACADEMY

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3-2. Regulatory Affairs for GEP & Utilities

강사명 이기붕
기간선택
365일 / 0원
  • 365일 / 0원
강의구성 총 23강 [969분]

1. GEP 및 공공시설에 대한 규제 업무
 - Instruments, Equipment and Facilities for Bio-Manufacturing
 - GEP, ASTM, ASME, GAMP
 - ISO, ICH-Guideline
 - 사례) ASME-PV for Fermentor and Autoclave

 - 사례) Homogenizer


2. New Trend in BioProcess
 - Single Use Technology-SUT
 - Continuous Process
 - DAQ & Smart Factory
 - DoE & QbD-PAT & RTRT 


3. Process Simulation (Process Optimization, Scheduling, Economic Evaluation)
 - Process Modeling and Simulation 개론
 - SuperProDesigner
 - SchedulePro

 - process simulation  

단원 강의명 강의시간 자료 샘플보기
1강 1강 :Regulatory Affairs for GEP & Utilities1 31분
2강 2강 :Regulatory Affairs for GEP & Utilities2 63분
3강 3강 :Regulatory Affairs for GEP & Utilities3 54분
4강 4강 :Regulatory Affairs for GEP & Utilities4 45분
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